Kornimate/medical-research-clean huggingface dataset:
the effects of wearing operation gown with cartoon characters on reducing preoperative anxiety in children: randomized controlled study

Conditions: Anxiety, Preoperative

Summary: the operating room environment can be frightening for pediatric patients. many techniques have been used to make the operating room environment less intimidating, including allowing parents to accompany part of this procedure, play therapy and various distraction strategies during the entrance to the operating room. in a survey study, it was reported that parents were expected to create hospital conditions with a more child-friendly atmosphere. in this context, it is thought that creating a warmer environment for children, including the clothes worn in the operating room, may reduce the anxiety level of children. in this study, investigators' aim was to investigate the effect of wearing an hospital gown with cartoon characters on the reduction of preoperative anxiety in children scheduled for orthopedic surgery by in the operating room.

pediatric patients aged between 4-12 years, who are planned to be operated by the orthopedic surgery clinic in bursa uludag university faculty of medicine hospital surgical theatre, will be randomized preoperatively by closed envelope method. one group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using the modified yale preoperative anxiety scale (m-ypas). afterwards, the patient will be asked to choose one of the hospital gowns they want to wear and put it on with parental assistance. the other group also will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using m-ypas. the patient will be asked to wear the hospital gown used in the hospital in routine practice with parental assistance. then the patients will be taken to the operating room as in the routine procedure. before induction of anesthesia in the operating room, another investigator will re-evaluate the child's anxiety level using the m-ypas scale. vital signs, analgesic use and duration of surgery will be recorded during the operation. afterwards, the satisfaction level of the parents will be evaluated.

Eligibility criteria:
inclusion criteria: * patients who are planned to have elective orthopedic surgery * patients whose american society of anesthesiologists (asa) physical status classification are between 1-3 * patients who have approved the informed consent form exclusion criteria: * motor and/or mentally retarded patients * patients with hearing-speech impairment * patients whose asa physical status classification iv-v * patients who do not accept informed consent and/or refused to participate in the study
a randomized, double-blind, placebo-controlled study of delandistrogene moxeparvovec (srp-9001) for duchenne muscular dystrophy (dmd)

Conditions: Muscular Dystrophy, Duchenne

Summary: the purpose of this study is to evaluate the safety and efficacy of exogenous gene transfer in dmd participants by measuring biological and clinical endpoints in three parts: two 48-week randomized, double-blinded, placebo-controlled periods (part 1 and part 2), and an open-label follow-up period (part 3). participants who are randomized to placebo in part 1 will have the opportunity for treatment with delandistrogene moxeparvovec in part 2. in order to provide a uniform approach to monitoring long-term safety and efficacy in participants who received srp-9001 in a clinical trial, the sponsor has amended study completion for this study to occur at week 130. therefore, participants have transitioned and will complete the remainder of the part 3 follow up visits in a long-term extension study, srp-9001-305 (nct05967351).


Eligibility criteria:
inclusion criteria: * established clinical diagnosis of dmd and documented dystrophin gene mutation of dmd phenotype. * indication of symptomatic muscular dystrophy by protocol-specified criteria. * ability to cooperate with motor assessment testing. * stable dose equivalent of oral corticosteroids for at least 12 weeks. * a frameshift mutation contained between exons 18 and 58 (inclusive). exclusion criteria: * impaired cardiovascular function on echocardiogram. * prior or ongoing medical condition on physical examination, electrocardiogram, or laboratory findings that could adversely affect participant safety, compromise completion of follow-up, or impair assessment of study results. * exposure to another investigational drug or exon skipping medication within 6 months of screening. * exposure to an investigational or commercial gene therapy product. * abnormal liver or renal function by protocol-specified criteria. other inclusion/exclusion criteria apply.

Keywords: duchenne muscular dystrophy gene-delivery dmd ambulatory pediatric north star ambulatory assessment (nsaa) percent dystrophin positive fibers (pdpf)
transcranial laser therapy in the rehabilitation of hemiplegic patients from ischemic stroke

Conditions: Hemiplegia

Summary: the aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.

transcranial laser therapy is applied with an inga(al)as diode laser.the laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. patients simultaneously performed a program of therapeutic exercises 3 days a week. outcome measures were the fugl-meyer upper extremity scale, which assessed upper limb motor function, and the barthel index, which assessed general functional disability.

Eligibility criteria:
inclusion criteria: 1. patients with hemiplegia secondary to cerebral stroke ischemic. 2. requirement of shaving the scalp area. 3. initiation of the tlt procedure begins between 70 and 100 days after stroke onset. 4. informed written consent before enrolling in the study. exclusion criteria: 1. hemiplegia secondary to hemorrhagic stroke. 2. metallic brain implants. 3. neurodegenerative disorders. 4. bilateral motor problems.

Keywords: transcranial laser therapy hemiplegia rehabilitation physiotherapy ischemic stroke
the rad-home project: a pilot study of domiciliary teleradiology

Conditions: Acute Congestive Heart Failure; Exacerbation of COPD; Pneumonia; Fractures; Osteomyelitis

Summary: aim of the study is to assess feasibility and safety of a public territorial radiology service for home hospitalized frail elderly patients whose health conditions discourage the transportation to hospital.


Eligibility criteria:
inclusion criteria: * immobilization or chairbound, * need for chest, pelvis/hips, joints, upper and lower limbs, hands and feet x-rays, * absence of definite delirium at enrollment according to the confusion assessment method, and * intermediate or high risk of delirium according to the criteria of inouye. exclusion criteria: * need of urgent examination (within 24 hours), * need of x-ray examinations not suitable at home.

Keywords: hospital at home radiology at home frail elderly
warning model of myocardial remodeling after acute myocardial infarction using multimodal feature structure technology

Conditions: Myocardial Infarction

Summary: acute myocardial infarction (ami) is one of the most important diseases threatening human life. the existing mi prognosis prediction scales mostly predict the incidence of death, recurrent mi and heart failure through 6-8 clinical text indicators, and the data are collected relatively simply. myocardial remodeling, as an adverse pathological change that can start and continue to progress in the early stage after myocardial infarction, is the main pathological mechanism of heart failure and death. however, there is no quantitative early-warning model of myocardial remodeling, and the clinical guidance of early intervention is lacking. our previous study found that cardiac magnetic resonance imaging can accurately quantify the necrotic area and recoverable myocardium in the edematous myocardium after myocardial infarction. in this study, machine learning algorithm, variable convolution network (dcn) and capsule network (capsnet) are used to build a new neural network architecture. structural feature extraction of multi-modal clinical image data such as mri and ultrasound is realized. combined with the established database of 3000 patients with myocardial infarction, the multimodal feature matrix will be constructed, and a variety of classifiers such as support vector machine (svm) and random forest (rf) will be used for quantitative prediction of myocardial remodeling, and the effects of different classifiers were evaluated. it is expected that this project will establish a quantitative early warning model of myocardial remodeling after acute myocardial infarction in line with the characteristics of chinese people. the same type of data outside the database will be used for verification to establish an efficient and stable early warning model.


Eligibility criteria:
inclusion criteria: * 1.patients with acute myocardial infarction, aged 18-80 years; 2.the time from onset to treatment is less than 72h 3.myocardial enzyme tni/tnt(+). exclusion criteria: * 1.patients with malignant tumors; 2.patients who could not receive conventional treatment 3.patients who did not receive coronary angiography, lacking anatomical and imaging data; 4.patients who have undergone cardiac surgery (except coronary artery bypass surgery)

Keywords: computer aided diagnosis myocardial remodeling early warning model myocardial infarction mri
double-blind sitagliptin add-on study in japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on ipragliflozin (mk-0431j-842)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a study to assess the safety and efficacy of the addition of sitagliptin in japanese participants with type 2 diabetes mellitus (t2dm) who have inadequate glycemic control on ipragliflozin, diet, and exercise therapy. the primary hypothesis of the study is that the addition of sitagliptin once daily compared with placebo provides greater reduction in hemoglobin a1c (hba1c) as assessed by change from baseline (week 0) to week 24.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * inadequate glycemic control on diet/exercise therapy and ipragliflozin monotherapy * hba1c ≥7.0% and ≤10.0% before study start exclusion criteria: * history of type 1 diabetes mellitus or a history of ketoacidosis * history of any of the following medications: thiazolidinediones (tzd) and/or insulin within 12 weeks prior to study participation, sitagliptin within 8 weeks prior to study participation. * currently has a urinary tract infection or genital infection with subjective symptom
rivaroxaban plus asa in embolic stroke of undetermined source(arest-esus)

Conditions: Stroke; Prevention

Summary: approximately 17% of all patients with stroke are classified as having esus, which is associated with a considerable rate of stroke recurrence 4-5 % per year. despite recent scientific advances in acute ischemic stroke treatment in recent decades,consensus treatment of all guidelines is still asa

this is an outcome assessor blind, randomized, parallel, placebo-controlled pilot study on ischemic stroke of undetermined source which will be conducted in bu ali sina hospital in sari, iran. patients with recent stroke with criteria of esus, will be randomized to rivaroxaban 2.5 mg bid plus asa 80 mg daily or asa 80 mg plus placebo (1:1 ratio) and have visit every 3 month until 1 year

Eligibility criteria:
inclusion criteria: 1. signing the inform consent 2. recent ischemic stroke ( 7-60) days with criteria of esus 3. only one risk factors of potential embolic source including: 1. ptfv1 in standard ecg ≥0.05 mm.s or ≥0.005 mv.s 2. lvh in standard ecg( sokolow index≥ 35 mm) or on echocardiography 3. moderate or severe valvular disorder on echocardiography (except ms) 4. pfo without indication of occlusion 5. left atrium enlargement in echocardiography exclusion criteria: 1. history of hypersensitivity to the investigational medicinal product 2. indication for anticoagulation 3. indication for dual antiplatelet therapy 4. contraindication to investigational medications 5. history of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding 6. gastrointestinal bleed or major surgery within 3 months 7. planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months 8. has-bled score \>3 9. severe non-cardiovascular comorbidity with life expectancy \< 3 months 10. severe renal failure, defined as glomerular filtration rate (gfr) \ 2.26 mg/dl 11. severe hepatic insufficiency, cirrhosis or bilirubin \>2x normal or ast/alt/ap \>3x normal 12. modified rankin scale of \>=4 at time of randomization or inability to swallow medications. 13. hemorrhagic transformation of infarction detected by brain ct or mri at the time of drug application 14. radiological or microbiological evidence of covid-19 infection

Keywords: esus doacs prevention
phase ii trial of decitabine in patients with chronic myelogenous leukemia chronic phase who are refractory to imatinib mesylate (gleevec)

Conditions: Chronic Myelogenous Leukemia

Summary: to determine the safety and efficacy of decitabine in patients with philadelphia chromosome-positive chronic myelogenous leukemia chronic phase that were previously treated with imatinib mesylate (sti 571) and became resistant/refractory or were found to be intolerant to the drug.


Eligibility criteria:
inclusion: * histologically confirmed diagnosis of cml chronic phase * ph chromosome-positive * previous treatment with imatinib mesylate resulting in: i) hematologic resistance / hematologic refractory: based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) imatinib mesylate intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment. * patients must have recovered from the side effects of previous cml therapy for chronic phase with the exception of hydroxyurea * age \>/= 2 years * bilirubin \</= 3 x the upper limit of normal (uln), sgot and sgpt \</= 3 x uln, except \</= 5 x uln in leukemic involvement of the liver, serum creatinine \</= 2 x uln * who performance status 0-3 * a negative serum hcg pregnancy test in patients of childbearing potential * able to give signed informed consent directly or through a parent or guardian for minors exclusion: * leukemic involvement of the central nervous system * active malignancy other than cml or non-melanoma cancer of the skin * previous treatment for cml with another investigational agent within 28 days of study entry * at study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks * patients who had received hematopoietic stem cell transplantation within 6 weeks of day 1 decitabine therapy * patients with grade 3/4 cardiac disease or any other serious concurrent medical condition. * patients who are pregnant or nursing. all patients of childbearing potential must practice effective methods of contraception while on study. * patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements * patients with systemic, uncontrolled infections

Keywords: chronic myelogenous leukemia cml cml-cp chronic phase decitabine 5-aza-2'deoxycytidine methylation sti 571 imatinib mesylate gleevec bcr/abl
compassionate use program with brivaracetam for the treatment of patients with epilepsy

Conditions: Epilepsy

Summary: this compassionate use program (cup) is setup to provide study patients with continuous access to brivaracetam (brv) for the time period between closures of the long-term follow up studies n01125, n01199, n01372, n01379, and n01315 and when brv is commercially available.


Eligibility criteria:
inclusion criteria: * patients with epilepsy who are participating in brivaracetam (brv) studies n01125, n01199, n01372, n01379 or n01315 * patients for whom the treating physician believes there is a continued benefit from the long-term administration of brv and other anti-epileptic therapies might not be suitable for the patient * female patients without childbearing potential are eligible * female patients with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the compassionate use program (cup) participation. the patient must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and inform the treating physician of any potential change in status * patient is considered reliable and capable of adhering to medication intake. * patient is informed of the details of this cup, is given ample time and opportunity to ask questions and consider his/her participation in this cup, and the patient or the legally authorized representative (lar) has provided verbal consent to participate, and, if required under local regulations, has given written informed consent exclusion criteria: * severe medical, neurological and psychiatric disorders, including current suicidal ideation or behavior, or laboratory values which may have an impact on the safety of the patient, as determined by the treating physician * poor compliance with medication intake in the previous brv study * participation in any clinical study of another investigation drug or device during the cup * pregnant or lactating woman
a randomized trial comparing ec-wpversus ep-wp as adjuvant therapy for operable breast cancer patients less than 40 years old

Conditions: Breast Neoplasms

Summary: manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. the purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.


Eligibility criteria:
inclusion criteria: * female patients, age 18\~40 * unilateral, operable, histologically confirmed adenocarcinoma of the breast * stage i-iii * primary surgery with clear margins plus axillary dissection * able to start protocol rx within 8 weeks of surgery * histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer: the immunohistochemical cut-off for er positive status was 1% or more staining in nuclei * her-2 negative (ihc 0,1+ or 2+ with a negative in situ hybridization test by chemotherapy * pathologically confirmed regional node-positive disease, or node-negative disease with high-risk factors (primary tumor diameter \>10 mm when histological grade iii, or tumor diameter \>20 mm when histological grade ii) * ecog performance status 0-1 * adequate cardiac, renal, hepatic and hematologic function exclusion criteria: * metastatic disease * bilateral breast cancer (synchronous or metachronous) * prior radiation therapy, hormonal therapy and chemotherapy for breast cancer * previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix) * her-2 positive (ihc 3+ or fish+) and or triple-negative breast cancer * documented history of cardiac disease contradiction anthracyclines * concurrent serious illness * peripheral neuropathy of ctc grade\>1 * history of hypersensitivity to drugs formulated in cremophor el polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations * pregnancy or lactation
carbohydrate rich drink reduces pre-endoscopic discomfort for patients going for elective endoscopic procedures

Conditions: Hunger; Depression; Anxiety; Vomiting; Abdominal Pain; Thirst; Fatigue; Lethargy

Summary: the study is a randomised controlled trial that aims to evaluate whether carbohydrate loading pre-endoscopy can improve patients' overall satisfaction and is not associated with negative impact on endoscopic quality or increased complications. a questionnaire will be completed by participants prior to endoscopy.

currently, the evidence of usage of cho is mainly for pre-operative patients and has never been evaluated for use in patients before endoscopic procedures which would also require them to fast substantially. using the same principles of perioperative care, the aim of this a pilot study is to evaluate if preload usage prior to endoscopic procedures will minimise patient discomfort secondary to fasting with alleviation of preprocedural thirst, hunger and anxiety symptoms. as a result, it may also reduce the urge for patients to drink and ingest prior to endoscopy, which may translate to last minute cancellation of procedures and wastage of precious resources. we believe it will improve overall patient experience and compliance to preprocedural fasting, without significant risks for patients or affecting the quality of endoscopy.

Eligibility criteria:
inclusion criteria: * planned for elective gastroscopy. * able to communicate to give informed consent and complete the questionnaire * 21 to 80 year old * asa physical status i-ii exclusion criteria: * medications that might impair gastrointestinal motility * conditions that may impair gastrointestinal motility, gastroesophageal reflux, pregnancy * potential for difficult airway management. * diabetic patients. * american society of anesthesiology (asa) physical status iii or more * unable to communicate to give informed consent or complete the questionnaire
observational study on pregnant women with chronic hepatitis b and their infants

Conditions: Hepatitis B, Chronic

Summary: the study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis b virus infection and mother-to-child transmission of hepatitis b virus.


Eligibility criteria:
inclusion criteria: 1. gestation of 4-32 weeks 2. hbsag+ \> 6 months, hbeag+/- 3. informed consent signed voluntarily 4. good compliance and able to be followed up as planned exclusion criteria: 1. coinfection with hepatitis c virus or human immunodeficiency virus; 2. comorbidities of other severe conditions that hinder compliance with follow ups and because of that, the subjects are anticipated to be unable to complete the project.; 3. unable or unwilling to use mobile health tools.

Keywords: chronic hepatitis b, mother-to-child transmission